Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Not Applicable

Active, not recruiting

• Conditions: Cancer, Breast; Cancer, Lung; Cancer, Ovarian; Cancer, Colorectal
• Interventions: Behavioral: aerobic exercise intervention; Other: control group; Behavioral: resistive training

• Registration Number: NCT02991677
• Lead Sponsor: Baltimore VA Medical Center

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Study Start: 2018-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis with cancer, stage I-IV
• History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
• Completion of chemotherapy > 6 months < 1 year
• Ability to walk on a treadmill
• Medical clearance from oncologist or primary care provider
• Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
• Score on Neuropathic Pain Scale >1
• Age 21-70

Exclusion Criteria

• Denial of CIPN
• Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
• Coronary artery disease
• History of >1 chemotherapy regimen
• Musculoskeletal conditions which preclude participation in an exercise training program
• Pregnancy
• Regular exerciser, defined as >90 minutes per week of aerobic exercise and any resistive training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic exercise	aerobic exercise intervention	Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.
control	control group	This is an attention control group with regular contact by study staff.
resistive training	resistive training	Intervention is for 12 weeks 3 times weekly with training on site.

Primary Outcome Measures

Name	Time	Method
Sensory pain	13 weeks	Thermal, mechanical, and vibration sensation by quantitative sensory testing

Secondary Outcome Measures

Name	Time	Method
Nerve fiber density	13 weeks	laboratory examination of skin biopsy samples for measurement of nerve fiber density

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States